FDA 510k For Factor Deficiency Test
Factor deficiency tests include blood tests that assess how well your blood clots. These tests can help identify deficiencies in clotting factors, which are proteins in the blood that help with clotting.
Intended Use of Factor Deficiency Test
A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as haemophilia and the corresponding normal gene).
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Factor Deficiency Test
Factor Deficiency Test Device Code and Regulation Number
|
Product Code |
Device |
Regulation Description |
Regulation Number |
Device Class |
| GGP | Test, Qualitative and Quantitative Factor Deficiency |
Factor deficiency test |
864.7290 |
2 |
|
GJT |
Plasma, coagulation factor deficient |
Test, Qualitative and Quantitative Factor Deficiency (GCP)
Intended Use: It is intended to be used in identifying factor IX deficiency, functional FVIII, von Willebrand Factor Antigen (VWF: Ag), and free protein S antigen in human plasma accordingly.
Device Description: It includes two lyophilized preparations, a substrate solution, and a buffer solution. The kit includes reagent A and reagent B, a substrate solution, a thrombin inhibitor, and a preservative, as well as a heparin antagonist, bovine serum albumin, and phospholipids.
Plasma, coagulation factor deficient (GJT)
Intended Use: It is intended to be used in identifying factor VIII deficiency, and factor XII activity in human plasma accordingly.
Device description: Factor VIII Deficient Plasma with VWF in normal human citrated plasma immunodepleted of factor VIII and added with an exogenous source of human von Willebrand Factor (vWF). Factor VIII has been assayed at less than 1% of normal activity levels, and vWF antigen and activity are >50%. Users will receive this plasma in small-volume aliquots (25 vials of 1.0 mL, and 25 vials of 1.5 mL). Vials are packaged in boxes and frozen during manufacturing. Factor XII activity in a patient’s plasma is determined using a modified activated partial thromboplastin time test (APTT). Patient plasma is diluted and added to deficient plasma, with correction of clotting time proportional to the factor’s concentration in the patient plasma, interpolated from a calibration curve.
Performance Testing (Analytical) for Factor Deficiency Test
- Expected value and range.
- Precision/Reproducibility
- Detection studies
- Linearity/assay reportable range
- Analytical Specificity/Interference
- Traceability (controls, calibrators, or method)
- Recovery
- Analytical Sensitivity
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Clinical Testing is NOT mandatory for 510k submission and IVDR CE Marking